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CTRI Number  CTRI/2024/01/061925 [Registered on: 29/01/2024] Trial Registered Prospectively
Last Modified On: 28/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of anaesthetic liquid vapour sevoflurane and desflurane from awakening under complete sleep anaesthesia in patients undergoing key hole gall blader operation patients in Regional Institute of Medical Sciences Hospital using randomly selection of patients. 
Scientific Title of Study   Comparative study of recovery characteristics between sevoflurane and desflurane in laparoscopic cholecystectomy patients under general anaesthesia in Regional Institute of Medical Sciences Hospital- a randomized clinical trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Takhelmayum Hemjit Singh 
Designation  Assistant Professor 
Affiliation  Regional Institute of Medical Sciences, Imphal West, Manipur 
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal
Lamphelpat, Imphal, Manipur, India. PIN 795004
Imphal West
MANIPUR
795004
India 
Phone  09436021445  
Fax    
Email  takhelhem@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Takhelmayum Hemjit Singh 
Designation  Assistant Professor 
Affiliation  Regional Institute of Medical Sciences, Imphal West, Manipur 
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal
Lamphelpat, Imphal, Manipur, India. PIN 795004
Imphal West
MANIPUR
795004
India 
Phone  09436021445  
Fax    
Email  takhelhem@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Takhelmayum Hemjit Singh 
Designation  Assistant Professor 
Affiliation  Regional Institute of Medical Sciences, Imphal West, Manipur 
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal
Lamphelpat, Imphal, Manipur, India. PIN 795004
Imphal West
MANIPUR
795004
India 
Phone  09436021445  
Fax    
Email  takhelhem@yahoo.com  
 
Source of Monetary or Material Support  
Regional Institute of Medical Sciences, Imphal, Manipur, India 
 
Primary Sponsor  
Name  Regional Institute of Medical Sciences 
Address  Imphal, Manipur, India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Takhelmayum Hemjit Singh  Regional Institute of Medical Sciences  Department of Anaesthesiology, Modular Operation Theatre Complex
Imphal West
MANIPUR 
09436021445

takhelhem@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Use of Desflurane during the maintenace period  Study participants will be randomized to receive desflurane in concentration decided by haemodynamics and bispectral index scoring for a duration of less than one hour. The study will be conducted for a period of one year.  
Intervention  Use of sevoflurane during the maintenance period  Study participants will be randomized to receive sevoflurane in concentration decided by haemodynamics and bispectral index scoring of less than one hour. The study will be conducted for a period of one year. . 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1.Patients of both sex with American Society of Anesthesiologist (ASA) physical grade I or II
2.Patients of age group 18 to 55 years of Manipuri ethnicity undergoing laparoscopic cholecystectomy under general anaesthesia.
 
 
ExclusionCriteria 
Details  1.History of use of hypnotics or antipsychotics in the last 30 days
2.History of cerebrovascular diseases, chronic kidney diseases, significant cardiovascular diseases, chronic obstructive pulmonary diseases, etc.
3.Pregnant patient, patient refusal and history of allergy to any medication
4.Surgeries lasting more than one hour.
5.Body mass index more than 30 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of this study will be the time interval from the stoppage of inhalational anaesthetics to the time to spontaneous eye opening, time to obey commands, time to extubation and time to reach modified Aldrete score of 9.  The assesment will be done from the stoppage of inhalational anaesthetic to spontaneous recovery, i.e at 5 and 10 minutes after the stoppage. 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcomes will includehemodynamics parameters such as blood pressure and heart rate at 5 minutes, 10th minutes, thereafter for every 10 minutes and also at immediate postoperative period, side effects such as coughing, emergence agitation, nausea and vomiting, laryngospasm, excessive secretion, desaturation, etc  The recording will be done at 5th, 10th, every 10 minutes intraoperatively and immediate postoperative 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   01/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [takhelhem@yahoo.com].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 31-12-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Sevoflurane and desflurane are the newer inhalational volatile anaesthetics with properties close to ideal and have been an important agent used in the maintenance of anesthesia. Some previous studies have highlighted that desflurane provided rapid and stable emergence than sevoflurane in many surgical day care procedures. Desflurane however has been not used in induction due to its propensity to cause airway irritation, cough, larngospasm and profuse secretion in some studies.  Laparoscopic cholecystectomy surgery is usually a minimal invasive one which offers reduced morbidities, lesser operative time and early return to normal activities.

The present study will be conducted to compare the recovery characteristics of sevoflurane and desflurane in laparoscopic cholecystectomy under general anaesthesia and will compare the time interval from the stoppage of inhalational anaesthetics to the time to spontaneous eye opening, time to obey commands, time to extubation and time to reach  modified Aldrete score of 9. The study has been planned as there is paucity of literatures comparing these two agents on laparoscopic cholecystectomy which is the most common operative procedure in the Institute and it has also not been undertaken in this part of our ethinicity

A total of 60 patients, aged 18 to 55 years belonging to American society of Anaesthesiologists (ASA) I and II, undergoing laparoscopic cholecystectomy under general anaesthesia will be divided into two groups (Group A and Group B) by block randomization. Group A patients will receive Sevoflurane as maintenance agent with concentration decided by Bispectral Index Score (BIS) and hemodynamics parameters whlie Group B patients will receive Desflurane as maintenance agent with concentration decided by Bispectral Index Score (BIS) and hemodynamics parameters.The time interval from the stoppage of inhalational anaesthetics to the time to spontaneous eye opening, time to obey commands, time to extubation and time to reach  modified Aldrete score of 9 will be recorded in minutes.The hemodynamics parameters such as blood pressure and heart rate at 5 minutes, 10th minutesthereafter for every 10 minutes and at immediate postoperative period, side effects such as coughing, emergence agitation, nausea and vomiting, laryngospasm, excessive secretion, desaturation, etc will also be assessed.

The findings and observations made during the entire study will be tabulated, graphically depicted whenever possible, statistically analysed and inference will be drawn. The study will be conducted after getting due approval from the Research Ethics Board of the Institute and after registration with the Clinical Trial Registry of India.

 
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